At the EPSCO Council held today (19 June 2015), Member States adopted a political agreement on a new Medical Devices Regulation, after more than two years of discussions at Council level.
Euromcontact, the European Association of Contact lens and lens care industry in the EU, welcomes this step towards a new regulatory framework governing medical devices. In particular, Euromcontact welcomes the inclusion of plano contact lenses in the scope of the new regulation, a change which has been supported by the Industry for many years. This will ensure the highest possible patient safety. Euromcontact calls on the European Parliament and Commission to support this approach in the trilogue negotiations that will begin soon under the Luxemburg Presidency.
However, Euromcontact expresses reservations about unclear patient and consumer safety standards relating to reprocessing of single use devices.
Euromcontact will now examine the text in detail and will comment further in due course.